Cytosorbents Corp Stock Price, News & Analysis

CytoSorbents (NASDAQ: CTSO) provided a regulatory update on DrugSorb-ATR, its FDA Breakthrough Device for blood purification. Following FDA's previous De Novo application denial, the company has received constructive feedback and will submit a new De Novo application with additional real-world data supporting their desired label indication for patients on ticagrelor undergoing urgent CABG surgery.

The FDA found no safety issues with the device and has proposed an expedited path for market authorization. CytoSorbents plans to file a pre-submission meeting request in October 2025, with a formal FDA meeting expected in Q4 2025. A regulatory decision is anticipated by mid-2026. Additionally, the company has withdrawn its Health Canada reconsideration request, planning to submit a new application after gaining clarity from the FDA process.

CytoSorbents Corporation (NASDAQ: CTSO) announces a global webinar titled "Turning the Tide in Sepsis and Septic Shock: Real World Insights with CytoSorb" scheduled for September 10, 2025, at 11:00 AM EDT. The webinar, hosted by CEO Dr. Phillip Chan, will feature international critical care experts sharing insights on using CytoSorb® blood purification therapy to treat sepsis and septic shock.

The distinguished panel includes experts from Switzerland, Hungary, and Germany who will discuss best practices for early and intensive CytoSorb treatment. The agenda covers how CytoSorb complements antibiotics, prevents organ failure, and achieves key treatment goals in sepsis, including controlling inflammation, stabilizing patients, removing toxins, and managing fluid overload.

CytoSorbents Corporation (NASDAQ: CTSO), a company specializing in blood purification for critical care and cardiac surgery, has announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference. The presentation is scheduled for September 8, 2025, at 11:30 AM ET at the Lotte New York Palace Hotel in New York.

Investors can access the live presentation through a webcast, and a replay will be available for 90 days on the company's investor relations website.

CytoSorbents (NASDAQ: CTSO) received an FDA appeal decision regarding its DrugSorb-ATR device, following the April 2025 De Novo application denial. While the FDA found no safety issues with the device, they upheld the denial citing the need for additional information to support the label indication for this FDA Breakthrough Device.

The FDA has proactively proposed a potential path forward for market authorization, and the company continues discussions with the Agency. CytoSorbents has the option to file another appeal with the FDA's CDRH Director within 30 days. The device aims to help heart attack patients requiring urgent CABG surgery while on ticagrelor, addressing the critical issue of perioperative bleeding risk.

CytoSorbents (NASDAQ: CTSO) reported Q2 2025 financial results showing revenue growth of 9% to $9.6 million compared to Q2 2024, primarily driven by 22% growth in Germany. The company achieved a net income of $1.9 million ($0.03 per share) versus a net loss in Q2 2024, while maintaining a gross margin of 70.9%.

Key developments include an FDA appeal hearing for DrugSorb™-ATR, with a final regulatory decision expected in 2025, and continued work with Health Canada following their Notice of Refusal. The company's cash position stands at $11.7 million as of June 30, 2025. Management expects to approach breakeven operations by the end of 2025 through improved execution and cost control measures.

The company announced an upcoming World Sepsis Day Global Webinar on September 10, 2025, highlighting CytoSorb's role in treating sepsis and septic shock, supported by recent positive clinical studies and meta-analyses showing significant mortality reduction.

CytoSorbents (NASDAQ: CTSO) highlights significant advancements in treating sepsis and septic shock using their CytoSorb® blood purification therapy. Recent studies demonstrate that early and intensive CytoSorb treatment substantially improves patient outcomes. Key findings include 74% 90-day survival rate in COVID-19 patients on CytoSorb and ECMO, and nearly doubled survival rates (70% vs. 37% predicted) in septic shock patients with early treatment.

The first meta-analysis of 744 septic shock patients showed significant improvements in survival, with CytoSorb reducing in-hospital mortality and halving 28-30 day mortality. The therapy works by removing toxic substances from bloodstream, controlling inflammation, and addressing multiple aspects of septic shock, complementing traditional antibiotic treatment.

CytoSorbents (NASDAQ: CTSO), a company specializing in blood purification for intensive care and cardiac surgery, has scheduled its Q2 2025 earnings release for August 7, 2025 after market close.

The company will host a conference call and webcast at 4:30 PM ET on the same day, featuring management presentations and a Q&A session. Participants can join via North American toll-free (1-800-836-8184) or international toll (1-646-357-8785) numbers.

CytoSorbents (NASDAQ: CTSO) provided regulatory updates regarding DrugSorb-ATR, its FDA-designated Breakthrough Device, in both the U.S. and Canada. The FDA has scheduled an appeal hearing for the company's supervisory review, expected to complete by August 2025.

In Canada, Health Canada issued a Notice of Refusal for the Medical Device License application. CytoSorbents plans to file a Level 1 "Request for Reconsideration" by July 25, 2025. DrugSorb-ATR is designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping Brilinta®. The company expects final regulatory decisions from both authorities by year-end 2025.

CytoSorbents (NASDAQ: CTSO) has filed an administrative appeal with the FDA for supervisory review of its DrugSorb-ATR Device De Novo request denial. The appeal was filed on June 18, 2025, following the FDA's denial letter from April 25, 2025. DrugSorb-ATR, a Breakthrough Device Designation recipient, aims to reduce bleeding severity in patients undergoing CABG surgery within two days of stopping Brilinta®.

The administrative appeals process includes a formal hearing with FDA's CDRH upper management, with a decision expected within 60 days of filing. Simultaneously, the company's application with Health Canada remains under advanced review, with a final regulatory decision expected in 2025.